IMPORT AND REGISTRATION

It has been decided to extend the date of applicability of this notification from 1.1.2003 to 1.4.2003 as per the conditions given below:

During this extended period of three months :

(a) The validity of Form 10 Licences, issued earlier shall be considered upto 31.3.2003.

(b) Drugs not requiring Form 10 Licenses and import of bulk drugs by the Drug Manufacturing Units (Formulators) having Drug Manufacturing Licences shall be continued upto 31.3.2003, as per the regulatory procedure followed earlier.

(c) However, any consignment of drugs, even if L.C. (Letter of Credit) is opened prior to 31.3.2003, would be eligible for import after 1.4.2003 only if the importer has ensured registration as per the provisions of GSR No. 604 (E).

(d) All other conditions for Import and Registration, including Fees for Test Licences and Form 10 Licenses shall be followed as per the provisions notified under GSR No. 604 (E) dated 24.8.2001.

IMPORT AND REGISTRATION

PREFACE

Government of India, Ministry of Health and Family Welfare has published a Gazette Notification GSR no. 604 (E) dated 24.08.2001 amending the various provisions of the Drugs & Cosmetics Rules, thereby introducing a new provision for the registration of the manufacturing premises of foreign drug manufacturer and the individual drugs prior to their import into the country. The notification has also introduced few other provisions viz. enhanced import licence fees, increased validity period of licence, deletion of exemption from requirement of import licence for bulk drugs for actual users, requirement of minimum 60% of retained shelf life for imported drugs and provisions for import of small quantities of new drugs by Govt. hospitals for treatment of their own patients etc.

Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. The applications can be made by authorized agents of foreign firms in India. The documents required for registration certificates have been clearly specified in the amendments. The validity of registration certificates will be 3 years from the date on which these are issued. A fee of 1500 USD is to be charged for the registration of overseas manufacturer's premises and fee of 1000 USD will be charged for every individual drug. The rules provide now for inspection of the premises of a foreign manufacturer by Indian Drug Authorities, whenever so required. In such cases, an additional fee of 5000 USD is to be charged. The rules also provided for payment of testing charges by registration holders. The foreign manufacturer or his authorised agent in India shall be liable to report any change in the manufacturing and testing process of a drug. However, no registration certificate shall be insisted in respect of an inactive bulk substance to be used as pharmaceutical aid for manufacture of drug formulation. The registration may be suspended or cancelled in the event any violation of the conditions for registration comes to notice. The new registration and import licence scheme shall also cover diagnostic kits viz. HIV I & II, HBsAg, HCV and blood group reagents.

According to new rules, import licence will be required for all types of drugs instead of existing import licence requirements for Schedule C & C (1) and Schedule X drugs only. Import licence in Form 10 would be granted after completing the registration of overseas manufacturers and their specific drugs to be imported. The import licence for specific drugs will be valid for 3 years from the date on which these are granted. The import licence fee has been kept Rs. 1000/- for a single drug and at the rate of Rs.100/- for additional drug. The fee of import licences for test and analysis of a drug has been kept Rs. 100/- for a single drug and at the rate of Rs. 50/- for each additional drug. The exemption from import licences for the import of bulk drugs by the formulations for actual use under Schedule D has been deleted. A provision has been made that only drugs with minimum 60% of retained shelf life shall be allowed to be imported in the country.

A separate provision has been made to enable the Govt. hospitals to import small quantities of essential new drugs for the treatment of their owm patients. The fee for such import licences has been kept Rs. 100/- for a single drug and the rate of Rs. 50/- for each additional drug.

The notification will come into operation with effect from 1st January 2003. In order to enable a smooth change over the new import requirements, it is proposed that all manufacturers/importers who are to obtain registration certificates for drugs, and import licences in January 2003, should submit their applications for registration certificates on or before 31.3.2002 and import licence applications not later than 30.9.2002, thereby giving minimum lead time to process their applications. Existing import of drugs under Form 10 licences will continue up to 31.12.2002. Since the existing validity of Form 10 Licences extends upto the end of next calendar year, it will be stipulated in Form 10 Licences issued w.e.f. 1.1.2002 that validity of such licences will terminate automatically on 31.12.2002.

The new scheme would take care of a long felt need for laying down import registration requirements similar to those adopted by various other countries.

The text of the notification can also be accessed from the website of the Ministry of Health & Family Welfare at the address file:///M|/websites_upto_23Jan03/ CDSCO_V6Jan03/html/http//www.mohfw.nic.in

This compilation includes, Chapter III of the Drugs & Cosmetics Act, 1940; Part IV of the Drugs & Cosmetics Rules, 1945 amended upto 24th August 2001; Related circulars issued to various agencies from time to time.

8. Standards of quality - 4[(1) For the purpose of this Chapter, the expression "standard quality" means-

(a) in relation to a drug, that the drug complies with the standard set out in 5[the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]

(2) The Central Government, after consultation with the Board and after giving by notification in the Official Gazette not less than three months' notice of its intention so to do, may by a like notification add to or otherwise amend 5[the Schedule], for the purposes of this Chapter, and thereupon 5[the Second Schedule] shall be deemed to be amended accordingly.

6[9. Misbranded drugs - For the purpose of this Chapter, a drug shall deemed to be misbranded-

(a) if it is so coloured, coated, powered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is, or

(b) if it is not labeled in the prescribed manner; or

(c) if its label or container or anything accompanying the drugs bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.]

1[9A. Adulterated drugs -For the purpose of this Chapter, a drug shall deemed to be adulterated, -

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only or a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) If any substance has been mixed therewith so as to reduce its quality or strength.

9B. Spurious drugs -For the purposes of this Chapter, a drug shall be deemed to be spurious-

(a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is truly a product.

9C. Misbranded cosmetics -For the purpose of this Chapter, a cosmetic shall be deemed to be misbranded -

(a) if it contains a colour which is prescribed; or

(b) if it is not labeled in the prescribed manner; or

(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

9D. Spurious cosmetics - For the purpose of this Chapter, a cosmetic shall be deemed to be spurious -

(a) if it is imported under a name which belongs to another cosmetic; or

(b) if it is an intimation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon its label or container the name of other cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity wit such other cosmetic; or

(c) if the label or container bears the name of an individual or a company purporting to be manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.]

10. Prohibition of import of certain drugs or cosmetics - From such 1date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import-

(a) any drug 2[or cosmetic] which is not of standard quality;

3[(b) any misbranded drug or misbranded 4[or spurious] cosmetic;]

5[(bb) any adulterated 4[or spurious] drugs;]

(c) any drug 2[cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;

6[(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container and thereof the true formula or list of 6[active ingredients contained in it together with the quantities thereof];]

(e) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed;

1[ (ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;]

(f) any drug 1[ or cosmetic] the import of which is prohibited by rule made under this Chapter.

Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or for personal use. Provided further that the Central Government may, after consultation with the Board, by notification in the official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class of drugs not being of standard quality.

3[10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest - Without prejudice to any other provision contains in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.]

11. Application of law relating to sea customs and powers of Customs Officers- (1) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 1878 (18 of 1978)4 shall, subject to the provisions of Section 13 of this Act, apply in respect of drugs and 5[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under this Act to perform the duties imposed thereby on a 6[Commissioner of Customs] and other officers of Customs, shall have the same powers in respect of such drugs 5[and cosmetics] as they have for the time being in respect of such goods as aforesaid.

7[(2) Without prejudice to the provisions of sub-section (1), the 6[Commissioner of Customs] or any officer of the Government authorized by the Central Government in his behalf, may detain any imported package which he suspects to contain any drug 5[or cosmetic] the import of which is prohibited under this Chapter and shall forthwith report such detection to the Drugs Controller, India and if necessary, forward the package or sample of any suspected drug 5[or cosmetic] found therein to the Central Drug Laboratories.

12. Power of Central Government to make rules - (1) The Central Government may, after consultation with 1[or on the recommendation of] the Board and after previous publication by notification in the Official Gazette, makes rules for the purpose of giving effects to the provisions of this Chapter.

2[Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]

(2) Without prejudice to the generality of the foregoing power, such rules may-

(a) specify the drugs or class of drugs 3[or cosmetics or classes of cosmetics] for import of which a licence is required, and prescribe the form and conditions of such licences, the authority empowered to issue the same, the fees payable therefor 4[and provide for the cancellation, or suspension of such licence in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which the licence is issued is not complied with;]

(b) prescribe the methods of test or analysis to be employed in determining whether a drug 5[or cosmetic] is of standard quality;

(c) prescribe in respect of biological and organometallic compounds, the units or methods of standardization; 5[(cc) prescribe under clause (d) of 6[Section 9A] the colour or colours which a drug may bear or contain for purposes of colourings;]

(d) specify the diseases or ailments which an imported drug may not purport or claim 7[to prevent, cure or mitigate] and such other effects which such drug may not purport or claim to have;

(e) prescribe the conditions subject to which small quantities of drugs, the import of which otherwise prohibited under this Chapter, may be imported for the purpose of examination, test or analysis or for personal use;

(f) prescribe the places at which drugs 5[or cosmetics] may be imported, and prohibit their import at any other places;

(g) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified imported drug or class of such drug, and prohibit the import of the said drug or class of drug after expiry of a specified period from the date of manufacture;

(h) regulate the submission by importers, and the securing of samples of drugs 1[or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis;

(i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs 1[or cosmetics] sought to be imported, the procedure of officers of Customs in dealing with such evidence, and the manner of storage at places of import of drugs 1[or cosmetics] detained pending admission;

(j) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter and the rules made thereunder of drugs 1[or cosmetics] imported for the purpose only of the transport through, and export from 2[India];

(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs 1[or cosmetics] 3[including the use of packing material which comes into direct contact with the drugs];

(l) regulate the mode of labeling drugs 1[or cosmetics] imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels;

(m) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the rules made thereunder;

(n) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any imported, patent or proprietary medicine containing such drug;

(o) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder of any specified drug or class of drugs 1[or cosmetic or class of cosmetics.]

4[13. Offences- (1) Whoever himself or by any other person on his behalf imports,-

(a) any drug deemed to be adulterated under Section 9A or deemed to be a spurious drug under section 9B or any spurious cosmetic referred to in Section 9D or any cosmetic of the nature referred to in clause (ee) of Section 10 shall be punishable with imprisonment for a term which may be extend to three years and a fine which may extend to five thousand rupees;

(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is prohibited under Section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees or with both;

(c) any drug or cosmetic in contravention of the provisions of any notification issued under Section 10A, shall be punishable with imprisonment for a term which may extend to three years or with fine which may extend to five hundred rupees, or with both.

(2) Whoever having been convicted of an offence -

(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to ten thousand rupees, or with both;

(b) under clause (b) of sub-section (1) is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees, or with both.

(3) The punishment provided by this section shall be in addition to any penalty to which the offender may be liable under the provisions of Section 11.]

14. Confiscation -When any offence punishable under Section 13 has been committed, the consignment of the drugs 1[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.

15. Jurisdiction -No Court inferior to that 2[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try and offence punishable under

(a) 'Import licence' means either a licence in Form 10 to import drugs, excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X);

(b) "licensing authority" means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and included any person to whom the power of a licensing authority may be delegated under Rule 22;

(c) "licence for examination, test or analysis" means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis.

(d) "manufacturer", includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and/or in other major countries;

(e) Registration Certificate" means a certificate issued under rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India'.

22. The licensing authority may with the approval of the Central Government by an order in writing delegate the power to sign licences and Registration Certificates, and such other powers as may be specified in the order to any other person under his control.

23. Import licences - An import licence in Form 10 shall be required for import of drugs excluding those specified in Schedule X, and an import licence in Form 10-A shall be required for the import of drugs specified in Schedule X.)

24. Form and manner of application for import licence - (1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these rules, or by the manufacturer's agent in India either having a valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules, and shall be accompanied by a licence fee of one thousand rupees for a single drug and an additional fee at the rate of one -3- hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer:

Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug.

(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under rule 27-A: Provided that in case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under rule 27-A, for reasons to be recorded in writing."

(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this rule, if the original is defaced, damaged or lost.

24-A. Form and manner of application for Registration Certificate -

(1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid whole sale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence -4- manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules and shall be accompanied by the fee specified in sub-rule (3) and the information and undertakings specified in Schedules D-1 and D-II duly signed by on behalf of the manufacturer.

(2) The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate.

(3) (i) A fee of one thousand and five hundred US dollars shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India.

(ii) A fee of one thousand US dollars shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug:

Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee to accompany shall be one thousand US dollars for each drug.

(4) The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104- Fees and Fines".

Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines", and the original receipt of the said transfer shall be treated as an equivalent to the bank challan subject to the approval by the Bank of Baroda that they have received the payment.

(5) The applicant shall be liable for the payment of a fee of five thousand US dollars for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under rule 22:

(6) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug.

(7) A fee of three hundred US dollars shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost."

(8) No Registration Certificate shall be required under these rules in respect of an inactive bulk substance to be used for a drug formulation, with or without Pharmacopoeial conformity."

25. Licences for import of drugs manufactured by one manufacturer - (1) A single application may be made, and a single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer:

(Provided that the drugs or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit: Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate licence shall be required in respect of drugs manufactured by each such factory.)

25-A. Conditions to be specified before a licence in Form 10 or Form 10-A is granted - (1) A licence in Form 10 or in Form 10-A shall be granted by the licensing authority having regard to-

(i) the premises, where the imported substances will be stocked are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies; and

(ii) the occupation, trade or business ordinarily carried out by the applicant: Provided that the licensing authority may refuse to grant a licence in Form 10-A in respect of any applicant where he is satisfied,-

(a) that the applicant has not complied with the provisions of the Act or these rules, or

(b) that by reasons of-

(i) his conviction under the Act or these rules or the Narcotic Drugs and Psychotropic Substances Act, (61 of 1985 ) or the rules made thereunder;

(ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted.

(2) Any person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for making a representation in the matter, make such orders in relation thereto as it thinks fit.

25-B. Registration Certificate for import of drugs manufactured by one manufacturer - (1) A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer:

Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit: Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.

26. Conditions of import licence.- An import licence shall be subject to the following conditions - (i) the manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9;

(ii) the licensee shall allow any Inspector authorized by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked in inspect the means, if any, employed for testing the substance and to that samples;

(iii) the licensee shall on request furnish to the licensing authority from every batch of each substance or form such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied;

(iv) if the licensing authority so directs the licensee shall not sale or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-rule until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the licensing authority;

(v) the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality and purity prescribed by Chapter III of the Act, or the Rules thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may in particular circumstances of the case be practicable, recall the issues already made from that batch; -10-

(vi) the licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particular of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorized in that behalf by the licensing authority:

(Provided that in respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain a separate record or register showing the following particulars, namely:

1.Name of the drug,

2.Batch Number,

3.Name and address of the manufacturer.

4.Date of transaction.

5.Opening stock on the business day,

6.uantity of drug received, if any, and the source from which received,

7.Name of the purchaser, his address and licence number,

8.Balance quantity of drug at the end of the business day,

9.Signature of the person under whose supervision the drugs have been supplied;)

(vii) the licensee shall comply with such further requirements, if any, applicable to the holders of import licences, as may be specified in any Rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months' notice.

27. Grant of import licence - On receipt of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall on being satisfied, that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 or Form 10-A, as the case may be.

27-A. Grant of Registration Certificate - (1) On receipt of an application for Registration Certificate in the Form and manner specified in rule 24-A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate in Form 41:

Provided further that if the application is complete in all respects and information specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months as the licensing authority, may deem fit.

(2) If the applicant does not receive the Registration Certificate within the period as specified in provisio to sub rule (1), he may appeal to the Central Government and the Central Government may after such enquire into the matter, as it considers necessary, may pass such orders in relation thereto as it thinks fit.

28. Duration of import licence - A licence, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from date of its issue.

Provided that if an application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.

28-A. Duration of Registration Certificate - A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue:

Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.

29. Suspension and cancellation of import licence - If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:

Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the said appellant an opportunity for representing his views, pass such orders in relation thereto as it thinks fit.

29-A. Suspension and cancellation of Registration Certificate - If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:

Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.

30. Prohibition of import after expiry of potency - No biological or other special product specified in Schedule C or C(1) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted by the prescribed test.

30-AA. Import of New Homeopathic medicines - (1) No New Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.

(2) The importer of a New Homeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.

(Explanation.- For the purpose of this rule, 'New Homeopathic medicine' means,-

(i) a Homeopathic medicine which is not specified in the Homeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the General Homeopathic Pharmacopoeia; or

(ii) which is not recognised in authoritative Homoeopathic literature as efficacious under the conditions recommended; or

(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognised in authoritative Homoeopathic literature as efficacious, under the conditions recommended.)

30-B. Prohibition of import of certain drugs - No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.)

31. Standard for certain imported drugs - No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the rules shall be applicable for determining whether any such imported drug complies with the said standards:

Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(1) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary:

Provided further that the licensing authority shall not allow the import of any drug having less than sixty per cent. residual shelf-life period as on the date of import:

Provided also that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow, the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug.

32. Packing and labelling of imported drugs - No drug shall be imported unless it is packed and labelled in conformity with the rules in Parts IX and X and further conforms to the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labelling shall conform to the rules in Parts IX and X and Schedule F(1).

32-A. Packing and labelling of Homoeopathic medicine - No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.

33. Import of drugs for examination, test or analysis - Small quantities of drugs the import of which is otherwise prohibited under Section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions:

(a) No drug shall be imported for such purpose except under a licence in Form 11;

(b) The licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the licence, or in such other places as the licensing authority may from time to time authorize;

(c) The licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof;

(d) The licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation, and the name of the manufacturer;

(e) The licensee shall comply with such further requirements, if any, applicable to the holders of licences for examination, test or analysis as may be specified in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice.

33-A. Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients - Small quantities of a new drug, as defined in rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:

(a) no new drug shall be imported for the said purpose except under a licence in Form 11-A, and the said drug has been approved for marketing in the country of origin;

(b) the licencee shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, under the supervision of its own Medical Officers at the place, specified in the licence or at such other places, as the licensing authority, may from time to time authorise;

(c) the licencee shall allow an Inspector authorised by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof;

(d) the licencee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the licence, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease;

(e) the licencee shall comply with such other requirements, if any, applicable to the holders of import licences for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice;

(f) the drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist;

(g) the quantity of any single drug so imported shall not exceed 100 average dosages per patient:

Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug a larger quantity.

'34-A. Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients - (1) An application for an import licence for small quantities of a new drug, as defined in rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or -21- such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be.

(2) The licensing authority may require such further particulars to be supplied, as he may consider necessary.

(3) Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.

(4) fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other branch or branches of Bank of Baroda, or any other Bank, as Notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fine

35. Cancellation of licence for examination, test or analysis - (1) A licence for examination, test or analysis may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued.

(2) A licensee whose licence has been cancelled may appeal to the Central Government within three months of the date of the order.

35-A. Cancellation of licence for import of small quantities of new drugs - (1) A licence for import of small quantities of a new drug, defined in rule 122-E, for the purpose of the treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, by a Government Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued or for contravention of any of the provisions of the Act and rules made thereunder.

(2) A licencee whose licence has been cancelled may appeal to the Central Government within three months from the date of the receipt of the order, and the Central Government may after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views, may pass such orders in relation thereto, as it thinks fit."

36. Import of drugs for personal use - Small quantities of drugs, the imports of which is otherwise prohibited under Section 10 of the Act, may be imported for personal use subject to the following conditions:

(i) the drugs shall form part of a passenger's bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;

(ii) the drugs shall be declared to the Customs Authorities if they so direct;

(iii) the quantity of any single drug so imported shall not exceed one hundred average does: Provided that the licensing authority may in an exceptional case in any individual case sanction the imports of a large quantity: Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:

(i) the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use;

(ii) the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner; and

(iii) the licensing authority grants a permit in respect of the said drug in Form 12-B.

Provided that such medicine may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission.

38. Statement to accompany imported drugs - All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the name and quantities of the drugs.

39. Documents to be supplied to the Customs Collector - Before drugs for the import of which a licence is not required are imported a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the drugs comply with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall be supplied to the Customs Collector.

40. Procedure for the import of drugs - (1) If the Customs Collector has reason to doubt whether any drugs comply with the provisions of Chapter III of the Act and Rules thereunder he may, and if requested by an officer appointed for this purpose by the Central Government shall, take samples of any drugs in the consignment and forward them to the director of the laboratory appointed for this purpose by the Central Government and may detain the drugs in the consignment of which samples have been taken until the report of the director of the said laboratory or any other officer empowered by him on this behalf, subject to the approval of the Central Government on such samples is received:

Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Customs Collector and to return the consignment or such portion thereof as may be required, the Customs Collector shall make over the consignment to the importer.

(2) If an importer who has given an undertaking under the proviso to sub-rule (1) is required by the Customs Collector to return the consignment or any portion thereof he shall return the consignment or portion thereof within ten days of receipt of the notice.

41. (1) If the director of the laboratory appointed for the purpose by the Central Government or any other empowered by him on this behalf subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall them to be destroyed.

Provided that the importer may within fifteen days of receipt of the report make a representation against the report to the Customs collector, and the Customs Collector shall forward the representation with a further sample to the licensing authority, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon which shall be final.

(2) If the director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the officer authorised in this behalf by the Central Government.

43. The drug specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule.

43-A. No drug shall be imported into India except through one of the following places, namely: - Firozepur Cantonment and Amritsar Railway Stations:

In respect of drugs imported by rail across the frontier with Pakistan. Ranaghat, Bongaon and Mohiassan Railway Stations:
In respect of drugs imported by rail across the frontier with Bangladesh.
Raxual: in respect of drugs imported by road and railway lines connecting Raxual in India and Birganj in Nepal.
Chennai, Calcutta, Mumbai Cochin and Nhava Sheva.
In respect of drugs imported by sea into India
Chennai, Calcutta, Mumbai, Delhi Ahmedabad and Hyderabad.
In respect of drugs imported by air into India.

43-B. Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder:

Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licences, the importer shall at the time of import into India, produce such import licences.

"FORM 8

(See rule 24)

Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945.

3. I/we _______________________________________________enclose herewith an undertaking in Form 9 dated ____________ signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics Rules, 1945.

4. I/we _______________________________________________enclose herewith a copy of Registration Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules, vide Registration Certificate No __________________________ Dated______________ issued through
M/s_______________________________________________ (name and full address _____________________________________________ valid upto _________________.

5. I/we _______________________________________________ hold a valid wholesale licence for sale or distribution of drugs or valid licence to manufacture drugs, under the provisions of the Act and rules made thereunder. A copy of the said licence is enclosed.

6. A fee of_______________ has been credited to Government under the Head of Account "0210 - Medical and Public Health, 04- Public Health,104- Fees and Fines" under the Drugs and Cosmetics Rules, 1945 - Central vide Challan No.____________, dated ____________ (attachedin original ).

Signature:________________________

Name:________________________

Designation:________________________

Seal/Stamp of Manufacturer's agent in India

Place: ______________

Date: _______________

" delete whichever is not applicable;'

FORM 8-A

(See rule 24)

Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945.

3. I/we _______________________________________________enclose herewith an undertaking in Form 9 dated ____________ signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics Rules, 1945.

*

4. I/we _______________________________________________enclose herewith a copy of Registration Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules, vide Registration Certificate No __________________________ Dated______________ issued through
M/s_______________________________________________ (name and full address _____________________________________________ valid upto _________________.

*

5. I/we _______________________________________________ hold a valid wholesale licence for sale or distribution of drugs or valid licence to manufacture drugs, under the provisions of the Act and rules made thereunder. A copy of the said licence is enclosed.

*

6. A fee of_______________ has been credited to Government under the Head of Account "0210 - Medical and Public Health, 04- Public Health,104- Fees and Fines" under the Drugs and Cosmetics Rules, 1945 - Central vide Challan No.____________, dated ____________ (attachedin original ).

Signature:________________________

Name:________________________

Designation:________________________

Seal/Stamp of Manufacturer's agent in India

Place: ______________

Date: _______________

" delete whichever is not applicable;'

FORM 9

(See Rule 24)

Form of undertaking to accompany an application for an import licence

Whereas _______________ of ______________ intends to apply for a licence under the Drugs & Cosmetics Rules, 1945, for the import into India, of the drugs specified below manufactured by us, we ________________ of _______________ hereby give the undertaking that for the duration of the said licence:

(1) the said applicant shall be our agent for the import of drugs into India;

(2) we shall comply with the conditions imposed on a licence by Rules 74 and 78 of the Drugs & Cosmetics Rules, 1945;

(3) we declare that we are carrying on the manufacture of the drugs mentioned in this undertaking at the premises specified below, and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of functions between the factories;

(4) we shall comply with the provisions of Part IX of the Drugs & Cosmetics Rules, 1945;

(5) every drug, manufactured by us for import under licence into India shall as regards strength, quality and purity conform with the provisions of Chapter III of the Drugs & Cosmetics Act, 1940, and the Drugs & Cosmetics Rules, 1945;

(6) we shall comply with such further requirements, if any, as may be specified by Rules, by the Central Government under the Act and of which the licensing authority has given to the licensee not less than four months' notice.

Names of drugs and classes of drugs

Particulars of premises where manufacture is carried on.

Date: ______________

Signed by or on behalf of the manufacturer

"FORM 10

(See rules 23 and 27)

Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945

Licence Number _________________ Date _______________
____________________________ _________________________________ (Name and full address of the importer) is hereby licensed to import into India during the period for which this licence is in force, the drugs specified below, manufactured by M/s _____________________________________ (name and full address) and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence.

2. This licence shall be in force from _________________ to_______________ unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported:

Place:____________

Date :____________

LICENSING AUTHORITY

Seal/Stamp

" delete whichever is not applicable.

Conditions of Licence

1. A photocopy of licence shall be displayed in a prominent place in a part of the premises, and the original licence shall be produced, whenever required.

2. Each batch of drug imported into India shall be accompanied with a detailed batch test report and a batch release certificate, duly signed and authenticated by the manufacturer with date of testing, date of release and date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer in India alongwith the registration holder and his authorised agent.

4. The licencee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution";

'FORM 10-A

(See rules 23 and 27)

Licence to import drugs specified in Schedule X to the Drugs and Cosmetic Rules, 1945

Licence Number ______________ Date ______________
_______________________________ ______________________________(Name and full address of the importer) is hereby licenced to import into India during the period for which this licence is in force, the drugs specified below, manufactured by M/s _____________________________________ (name and full address) and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence.

2. This licence shall be in force from _________________ to_______________ unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported:

Place:____________

Date :____________

LICENSING AUTHORITY

Seal/Stamp

" delete whichever is not applicable.

Conditions of Licence

1. A photocopy of licence shall be displayed in a prominent place in a part of the premises, and the original licence produced, whenever required.

2. Each batch of drug imported into India shall be accompanied with a detailed batch test report and a batch release certificate, duly signed and authenticated by the manufacturer with date of testing, date of release and date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer in India alongwith the registration holder and his authorised agent.

4. The licencee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution";

Form 11

[See Rule 33]

Licence to import drugs for the purpose of examination, test or analysis

I ______________________ of ________________ is hereby licensed to import from _________________the drugs specified below for the purposes of examination, test or analysis at _______________or in such other places as the licensing authority may from time to time authorize.

2. This licence is subject to the conditions prescribed in the Rules under the Drugs & Cosmetics Act, 1940.

3. This licence shall, unless previously suspended or revoked, be in force for a period of one year from the date specified below:

Names of drugs

Date :____________

Quantities which may be imported

Licensing Authority

'FORM 11- A

(See rule 33-A)

Licence to import drugs by a Government Hospital or Autonomous
Medical Institution for the treatment of patients

Licence No.____________________ Date ____________________Dr__________________________ Designation________________of___________________
___________________________(Name of College/ Hospital/ Autonomous Institution) is hereby licensed to import from M/s _______________________ (name and full address) the drugs specified below for the purpose of treatment of patients for the disease (name of the disease) _______________________ at ______________________________ or in such other places as the licensing authority may from time to time authorise.

2. This licence shall, unless previously suspended or revoked, be in force for a period of one year from the date of issue specified above.

3. Names of drugs to be imported:

Names of drug

Quantity which may be imported

Place :____________

Date :____________

LICENSING AUTHORITY

Seal/Stamp

Conditions of Licence

1. The licence shall be displayed in the Office of the Medical Superintendent of Government Hospital /Head of Institution of Autonomous Medical Institution.

2. The licensee shall store the drugs imported under this licence under proper storage conditions.

3. The drugs imported under this licence shall be exclusively used for the treatment of patients, and a record shall be maintained in this regard, by a registered pharmacist giving the full name(s) and address (es) of the patients, diagnosis, dosage schedule, total quantity of drugs imported and issued, and shall be countersigned by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution which shall be produced, on demand by an Inspector appointed under the Act.

Form 12

[See Rule 34]

Application for licence to import drugs forpurpose of examination, test or analysis

I _____________________________resident of ___________ by occupation __________ hereby apply for a licence to import the drugs specified below for the purposes of examination, test or analysis at _____________ from ___________ and I undertake to comply with the conditions applicable to the licence.

A fee of rupees of fifteen has been credited to the Government under the Head of Account â€œ0210- Medical & Public Health, 04-Public Health, 104-Fees & Finesâ€ under the Drugs & Cosmetics Rules, 1945-Central vide treasury receipt attached.

Names of drugs and classes of drugs
Quantities

Date :____________
Signature: ______________

Form 12-A

[See Rule 36, Second Proviso]

Application for the issue of a permit toimport small quantities of drugs for personal use

I _____________________________ resident of _____________ by occupation _______________ hereby apply for a permit to import the drugs specified below for personal use from ___________________I attach a prescription from a registered medical practitioner in regard to the need for the said drugs.

Names of drugs
Quantities

Date :____________
Signature: ______________

FORM 12-AA

(See rule 34A)

Application for licence to import small quantities of new drugs by a Government
Hospital or Autonomous Medical Institution for the treatment of patients.

--------------------------

I, ___________(name and designation) ____________________________of __________________________ _________________________(name of the Hospital/Autonomous Medical Institution)hereby apply for a licence to import small quantities of new drugs specified below for the purpose of treatment of patients for the disease __________________(name of the disease) at _____________________________________________ (name and place of the hospital) and I undertake to comply with the conditions applicable to the licence and other provisions of the Drugs and Cosmetics Act , 1940 and the rules made thereunder, from time to time.

1. A fee of rupees_________________ has been credited to Government under the Head of Account â€œ0210- Medical and Public Health, 04- Medical and Public Health, 104- Fees and Finesâ€ under the Drugs and Cosmetics Rules, 1945 â€“ Central vide Challan No.________, dated ________, (attached in original).

2. Name of new drug to be imported: -

Names of drug

Quantity which may be imported

Place :____________

Date :____________

Signature ____________________________

Name_______________________________

Seal/Stamp___________________________

CERTIFICATE

Certified that the drugs specified above for import are urgently required for the treatment of patients suffering from________________________________and that the said drug(s) is /are not available in India.

Permit for the import of small quantities of drugs for personal use.

2. This permit is subject to the conditions prescribed in the Rules under the Drugs & Cosmetics Act, 1940.

3. This permit shall, unless previously suspended or revoked, be in force for a period of six months from the date specified below.

Names of drugs
Quantities which may be imported

Date :____________
Licensing Authority.

Form 40

(See rule 24-A)

Application for issue of Registration Certificate for import of drugs into India
under the Drugs and Cosmetics Rules, 1945.

*I/We____________________________________ _________________Name and full address) hereby apply for the grant of Registration Certificate to the manufacturer, M/s ______________________________________ (full address with telephone, fax and E-mail address of the foreign manufacturer) for his premises, and manufactured drugs meant for import into India.

1. Names of drugs for registration.

(1)

(2)

(3)

2. I/We enclose herewith the information and undertakings specified in Schedule D (1) and Schedule D (II) duly signed by the manufacturer for grant of Registration Certificate for the premises stated below.

3. .A fee of _________________ for registration of premises, the particulars of which are given below, of the manufacturer has been credited to the Government under the Head of Account â€œ0210-Medical and Public Health, 04-Public Health, 104-Fees and Finesâ€ under the Drugs and cosmetics Rules, 1945 â€“ Central vide Challan No._________, dated _________, (attached in original).

4. A fee of _________________ for registration of the drugs for import as specified at Serial No.2 above has been credited to the Government under the Head of Account â€œ0210-Medical and Public Health, 04-Public Health, 104-Fees and Finesâ€ under the Drugs and cosmetics Rules, 1945 â€“ Central vide Challan No._________, dated ________, (attached in original).

5. Particulars of premises to be registered where manufacture is carried on:

Address (es) ___________________________________

Telephone: ____________________________________

Fax: _________________________________________

E- mail: ______________________________________

I/we undertake to comply with all the terms and conditions required to obtain Registration Certificate and to keep it valid during its validity period.

PLACE:

DATE:

Signature ________________________ Name ______________

Designation ________________

Seal/Stamp of manufacturer or his authorised agent in India.

(Note:- In case the applicant is an authorized agent of the manufacturer in India, the Power of Attorney is to be enclosed). whichever is not applicable.

Form 41

(See rule 27-A)

Registration Certificate

Registration Certificate to be issued for import of drugs into India
under Drugs and Cosmetics Rules, 1945.

Registration Certificate No.________ Date ________
M/s ___________________________(Name and full Address of registered office) ___________________ _______________________________________having factory premises at____________________________ (full address) has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate.

2. Name (s) of drugs, which may be imported under this Registration Certificate.

(1)

(2)

(3)

3. This Registration Certificate shall be in force from ___________ to_______________unless it is sooner suspended or cancelled under the rules.

4. This Registration Certificate is issued through the office of the manufacturer or his authorised agent in India M/s (name and full address)_________________________ ___________________________________who will be responsible for the business activities of the manufacturer, in India in all respects.

5. This Registration Certificate is subject to the conditions, stated below and to such other conditions as may be specified in the Act and the rules, from time to time.

I/we undertake to comply with all the terms and conditions required to obtain Registration Certificate and to keep it valid during its validity period.

PLACE________________________

DATE________________________

LICENSING AUTHORITY

Seal/Stamp;

Conditions of the Registration Certificate

1. The Registration Certificate shall be displayed at a prominent place by the authorised agent.

2. No drug shall be registered unless it has a free sale approval in the country of origin, and/or in other major countries.

3. The manufacturer or his authorised agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, 1945.

4. The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any drug pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the drug is marketed/sold or distributed.

The despatch and marketing of the drug in such cases shall be stopped immediately, and the licensing authority shall be informed immediately. Further action in respect of such stopped marketing of drug shall be followed as per the direction of the licensing authority. In such cases, action equivalent to that taken with reference to the concerned drug in the country of origin or in the country of marketing shall be followed in India also, in consultation with the licensing authority. The licensing authority may, however, direct any further modification to this course of action, including the withdrawal of the drug from Indian market within 48 hours time period.

5. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in packaging, or in labelling or in testing, or in documentation of any of the drug pertaining to this Registration Certificate.

In such cases, where there shall be any major change/modification in manufacturing, or in processing or in testing, or in documentation as the case may be, at the discretion of the licensing authority, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separate application along with the registration fee, as specified in clause (ii) of sub rule (3) of rule 24-A.

6. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and /or address of the registered office/ factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premisesâ€.

SCHEDULE D

[See Rule 43]

Class of drugs

Extent and conditions of exemption

1. Substances not intended for medicinal use All provisions of Chapter III of the Act and Rules thereunder subject to the conditions that if the substance is imported in bulk, the importer shall certify that the substance is imported for non-medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or is intended for some purposes other than medicinal use or is intended for some purposes other than medicinal use or is of commercial quality.

2.1[***]

3.1[***]

3[4. The following substances, which are used All provisions of Chapter III of the Act both as articles of food as well as drugs: -- and Rules thereunder.

(ii) Farex, Oats, Lactose and all other similar cereal preparations whether fortified with vitamins or otherwise expecting those for parenteral use.

(iii) Virol, Bovril, Chicken essence and all other similar predigested food.

4(iv) Ginger, Pepper, Cumin, Cinnamon and all other similar spices and condiments unless they are specifically labelled as conforming to the standards in the Indian Pharmacopeia or the official pharmacopoeias and the official compendia of the drug standards prescribed under the Act and Rules made thereunder.

SCHEDULE D (I)

(See rule 21 (d) and rule 24 A)

Information and undertaking required to be submitted by the manufacturer or his authorised agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a Computer Floppy.

________________________

1. Particulars of the manufacturer and manufacturing premises

1.1 Name and address of the manufacturing premises (telephone No, Fax No.E-mail address) to be registered.

1.2. Name(s) and address(es) of the Proprietor/Partners/Directors.

1.3. Name and address of the authorised Agent in India, responsible for the business of the manufacturer.

1.4 A brief profile of the manufacturerâ€™s business activity, in domestic as well as global market.

1.5 A copy of Plant Master File (duly notarised)

1.6 A copy of Plant Registration/approval Certificate issued by the Ministry of Health/National Regulatory Authority of the foreign country concerned (duly notarised)

1.7. A brief profile of the manufacturerâ€™s research activity.

2. Particulars of the manufactured drugs to be registered under Registration Certificate.-

2.1 Names of drugs (Bulk/Formulation/Special product) to be registered meant for import into and use in India:

2.2 A copy of the approved list showing the bulk drugs / formulations / special products mentioned in 2.1 above are permitted for manufacturing/marketing in the country of origin, (duly notarised).

2.3 A copy of Good Manufacturing Practice (GMP) certificate, as per WHO- GMP guidelines, or Certificate of Pharmaceutical Products (CPP), issued by the National Regulatory Authority of the foreign country concerned, in relation to the bulk drugs or formulations or special products, meant for import into India:

2.4 The domestic prices of the drugs to be registered in India, in the currency of the country of origin:

2.5 The name(s) of the drug(s), which are original research products of the manufacturer.

3. Undertaking to declare that: -

3.1 We shall comply with all the conditions imposed on the Registration Certificate, read with rules 74 and 78 of the Drugs and Cosmetics rules, 1945.

3.2 We declare that we are carrying on the manufacture of the drugs mentioned in this Schedule, at the premises specified above, and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of

3.3 We shall comply with the provisions of Part IX of the Drugs and Cosmetics Rules, 1945:

3.4 Every drug manufactured by us for import under the Registration Certificate into India shall be as regard strength, quality and purity conforms with the provisions of Chapter
III of Drugs and Cosmetics Act, 1940 and Part IV of the Drugs and Cosmetics Rules, 1945, and their amendments from time to time:

3.5 We shall from time to time report for any change or manufacturing process, or in packaging, or in labelling, or in testing, or in documentation of any of the drugs, pertaining to the Registration Certificate, to be granted to us. Where any change in respect of any of the drugs under the Registration Certificate has taken place, in respect of any of the above matters, we shall inform the same to the licensing authority, in writing within 30 days from the date of such changes. In such cases, where there will be any major change/modification in manufacturing or in processing or in testing, or in documentation, as the case may be, at the discretion of the licensing authority, we shall obtain necessary approval within 30 days by submitting a separate application, along with the registration fee as specified in clause (ii) of sub rule (3) of rule 24-A.

3.6 We shall from time to time report for any administrative action taken due to adverse reaction, viz. market withdrawal regulatory restriction, or cancellation of authorisation and/or â€œ not of standard quality reportâ€ of any drug pertaining to the Registration Certificate declared by any Regulatory Authority of any country where the drug is marketed/sold or distributed. The despatch and marketing of the drug in such cases, shall be stopped immediately and the licensing authority shall be informed immediately. Further action in respect of stop marketing of drug shall be taken as per the directions of the licensing authority. In such cases, action equivalent to that taken with reference to the concerned drug(s) in the country of origin or in the country of marketing will be followed in India also, in consultation with the licensing authority. The licensing authority may direct any further modification to this course of action, including the withdrawal of the drug from Indian market within 48 hours time period.

3.7 We shall comply with such further requirements, if any, as may be specified, by the Government of India, under the Act and the rules, made thereunder.

3.8 We shall allow the licensing authority and/or any person authorised by him in that behalf to enter and inspect the manufacturing premises and to examine the process/procedure and documents in respect of any drug manufactured by us for which the application for Registration Certificate has been made:

3.9 We shall allow the licensing authority or any person authorised by him in that behalf to take samples of the drugs concerned for test, analysis or examination, if considered necessary by the licensing authority.

PLACE :

DATE :

Signature of the manufacturer

Seal/Stamp

SCHEDULE D (II)

(See rule 21 (d) and rule 24 A)

Information required to be submitted by the manufacturer or his authorised agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy.

1. GENERAL

1.1 Name of the drug/formulation/special product, a brief description and the therapeutic class to which it belongs.

1.2. Regulatory status of the drug. Free Sale Certificate and/or Certificate of Pharmaceutical Products (CPP) issued by the Regulatory Authority of the country of origin. Free sale approval issued by the Regulatory Authorities of other major countries.

1.3. Drugs Master File (DMF) for the drug to be registered (duly notarised).

1.4 GMP Certificate in WHO formats or Certificate of Pharmaceutical Products (CPP) issued by National Regulatory Authority of the country of origin (duly notarised).

1.5 List of countries where marketing authorisation or import permission for the said drug is granted with date (respective authorisation shall be enclosed).

1.6 List of countries where marketing authorisation or import permission for the said drug is cancelled/withdrawn with date.

1.7. List of countries where marketing authorisation or import permission for the said drug is pending since (date).

1.8 Domestic price of the drug in the currency followed in the country of origin.

1.9 List of countries where the said drug is patented.

2. CHEMICAL AND PHARMACEUTICAL INFORMATION OF DRUGS.

2.1 Chemical name
Code name or number, if any
Non-proprietary or generic name, if any
Structure
Physico-chemical properties

2.2 Dosage form and its composition,
Qualitative and Quantative composition in terms of the active substance(s) and excipient(s)
List of active substance(s) separately from the constituent(s) of excipients.

2.3 Specifications of active and inactive ingredient(s) including pharmacopeial references.

2.4 Source of active ingredient(s), name and address.

2.5 Tests for identification of the active ingredient(s),
Method of its assays and tests for impurity profile with reference standards for the impurities (Protocol to be submitted along with reference standards for the impurities/relative substances).

2.6 Outline method and flow chart of manufacture of the bulk drug or finished formulation or special product.

2.7 Detailed test protocol for the drug with pharmacopeial reference or in house specification as approved by the registration authority, in the country of origin.

2.13 Three samples of medicinal product/drug and outer packaging are to be submitted with batch certificates. Additional samples as well as reference substances with batch certificates including date of manufacture, shelf life, storage conditions of reference substance may be required both during registration procedure and during validity of registration decision.

2.14 Batch test reports/certificate of five consecutive production batches in details of the medicinal product are to be submitted for every site of manufacturing premises.

2.15 Manner of labelling as per rule 96 of the Drugs and Cosmetics Rules, 1945.

2.16 Package insert.

2.17 Details of safety handling procedure of the drug.

2.18 Details of PMS study report for marketing period not exceeding five years.

3. BIOLOGICAL ANDBIOPHARMACEUTICAL INFORMATION OF DRUGS.

3.1 Biological control tests applied on the starting material, if applicable.

3.2 Biological control tests applied on the intermediate products, if applicable.

3.3 Biological control tests applied on the finished medical products, if applicable.

3.4 Stability of the finished products in terms of biological potency of the drug, if applicable.

4. PHARMACOLOGICAL AND TOXICOLOGICAL INFORMATION OF DRUGS

Executive summary of the product is to be submitted mentioning the specific and general pharmacological actions of the drug and pharmacokinetic studies on absorption, metabolism, distribution and excretion. A separate note is to be given on acute and sub-acute toxicity studies and long term toxicity studies. Specific studies on reproductive toxicity, local toxicity and carcinogenic activity of the drug is to be elaborated, as far as possible.

5. CLINICAL DOCUMENTATION

A new drug as defined under rule 122-E of the Drugs and Cosmetics Rules, 1945 is required to be permitted separately by the licensing authority under rule 122-A of the said rules prior to its registration. Such a new drug requires a brief summary on clinical documentation, along with permission under 122-A of the said rules for its Registration Certificate.

6. LABELLING AND PACKAGING INFORMATION OF DRUGS.

6.1 Labels should conform as per the specifications under the Drugs and Cosmetics Rules, 1945.

6.2 Package insert should be in English and shall indicate the following therapeutic indications: -

Posology and method of administration.
Contra-indications.
Special warnings and special precautions for use, if any.
Interaction with other medicaments and other forms of interation.
and lactation, if contra-indicated.
Effects of ability to drive and use machines, if contra-indicated.
Undesirable effects/side effects.
Antidote for overdosing.

6.3 Package insert should indicate the following pharmaceutical information:-

List of excipients.
Incompatibilities.
Shelf life in the medical product as packaged for sale.
Shelf life after dilution or reconstitution according to direction.
Shelf life after first opening the container.
Special precautions for storage.
Nature and specification of the container.
Instructions for use/handling.

7. SPECIFIC INFORMATION REQUIRED FOR THE SPECIAL PRODUCTS (to be supplied, separately in annexure, as "A", "B" and "C".)

The information submitted above is true to the best of my knowledge and belief.

PLACE :

DATE :

Signature of the manufacturer

Seal/Stamp

NB:

1. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.

2.Information relating to Serial No. 4 and Serial No.5 are not applicable for drugs figuring in Indian Pharmacopeia and also for the drugs figuring in United States of Pharmacopeia, European Pharmacopeia, and British Pharmacopeia provided such drugs have already been approved for marketing in India for the applicant under rules 122 A, 122B, 122C or 122D of the Drugs and Cosmetics Rules, 1945.

ANNEXURE-A

(See Schedule D-II, item No.7)

INFORMATION TO BE SUBMITTED IN SCHEDULE D-II SPECIFIC INFORMATION REQUIRED FOR THE BLOOD PRODUCTS.

A product dossier showing the: -

2. Details of Fractionation Centre, Regulatory Status, Method of Fractionation and Control Processes.

3. Details of viral inactivation process for enveloped and non-enveloped virus(es) and viral validation studies to assess the viral load of the product. Testing of viral screening at any stage is to be high lighted with the details of the kits used with their respective sensitivity and specificity.

4. Bulk filtration prior to pharmaceutical packing giving the full details of Micro-filtration or nanofiltration followed.

5. Complete details of pharmaceutical processing and unitisation.

6. Test protocol of the product showing the specifications and pharmacopeial method followed for various testing parameters. Specific batch test report for at least 3 batches showing the specifications of each testing parameter.

7. Pack size and labelling.

8. Product Insert.

9. Specimen Batch Release Certificate issued by the National Regulatory Authority of the country of origin.

Specific processings like safe handling, material control, area control, pasteurisation, stability studies, storage at quarantine stage and finished stage and packaging should be highlighted in the product dossier.

The information submitted above is true to the best of my knowledge and belief.

PLACE :

DATE :

Signature of the manufacturer

Seal/Stamp

NB:

1. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.

ANNEXURE-B

(See Schedule D-II, iem No.7)

INFORMATION TO BE SUBMITTED IN SCHEDULE D-II SPECIFIC INFORMATION REQUIRED FOR THE DIAGNOSTIC KITS

A product dossier showing the:

1. The details of source antigen or antibody as the case may be and characterisation of the same. Process control of coating of antigen or antibody on the base material like Nitrocellulose paper, strips or cards or ELISA wells etc. Details composition of the kit and manufacturing flow chart process of the kit showing the specific flow diagram of individual components or source of the individual components.

2. Test protocol of the kit showing the specifications and method of testing. In-house evaluation report of sensitivity, specificity and stability studies carried out by the manufacturer.

3. The report of evaluation in details conducted by the National Control Authority of country of origin. Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter.

4. The detailed test report of all the components used/packed in the finished kit.

5. Pack size and labelling.

6. Product insert.

Specific evaluation report, if done by any laboratory in India showing the sensitivity and specificity of the kit.

The information submitted above is true to the best of my knowledge and belief.

PLACE :

DATE :

Signature of the manufacturer

Seal/Stamp

NB:

1. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.

ANNEXURE-C

(See Schedule D-II, item No.7)

INFORMATION TO BE SUBMITTED IN SCHEDULE D-II SPECIFIC INFORMATION REQUIRED FOR VACCINES

A product dossier showing the:

2. Details flow chart of manufacturing process showing all the details of in process control on toxicity, potency study and stability data of the final bulk and the final finished product including the storage temperature.

3. Complete details of chemical and pharmaceutical data for the product.

Composition and dosage form â€“ method of manufacture with detailed flow chart- control of starting material- control tests on intermediate and finished products- certificate of analysis of finished products- validation of critical manufacturing steps.

4. Test protocol of the vaccines showing the specification and method of testing including pharmacopeial specification.

5. Specimen batch test report for at least consecutive three batches showing the specification of each testing parameter.

6. The detailed test reports of all the components used/packed in the finished vaccine.

7. Pack-size and labelling.

8. Product insert.

9. Specimen batch release certificates issued by the National Regulatory Authority of the country of origin.

10. Summary of pre-clinical and clinical data including:

(a) Prescribing information.

(b) Pharmacological and toxicological data pertaining to tests on animals

Characterisation of immuno response and safety study in human use, in specific conditions.

Specific information on source of seed strain, its characterisation, inactivation etc and processings like safe handling, material control, area control, process control, stability studies, storage at quarantine stage and finished stage, packaging should be highlighted in the product dossier.

Specimen production and quality control protocols for atleast three consecutive lots showing the specifications for each quality control parameter including pharmacopeial requirement shall be submitted for study.

The information submitted above is true to the best of my knowledge and belief.

PLACE :

DATE :

Signature of the manufacturer

Seal/Stamp

NB:

1. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.

2. All vaccines shall be new drugs unless certified otherwise by the licensing authority approved under rule 21 of the Drugs and Cosmetics Rule, 1945, A copy of approval of the vaccine issued by the said licensing authority is to be enclosed, prior to issue of Registration Certificate of the said vaccines

RELATED CIRCULARS ISSUED TO VARIOUS AGENCIESFROM TIME TO TIME

No. 18-8/2000-DC

Directorate General of Health Ser vices

Nirman Bhawan, New Delhi

Dated the 6th March 2002

To

The Ajit Dangi,

Director General,

Organization of Pharmaceutical Producers of India,

Cookâ€™s Building, 324, Dr. Dadabhoy Naoroji Road,

Fort, Mumbai- 400 001.

Sub: - GSR 604 (E) on Import and Registration-issued by Ministry of Health and Family Welfare (Issue of Form 10 licence on and from 1st January 2002 with the validity period upto 1/12/2002).

Sir,

Please refer to your letter no. MC-1-2002/100 dated 18.2.2002 on the above subject requesting for grant extension of three months to manufacturers / importers for filing their application for registration certificates i.e. extension up to June 30, 2002. Also, you have expressed youâ€™re your concerns on certain aspect of regulation made under GSR no. 604 (E) dated 24.8.2001.

The concerns expressed in your letter have been duly examined. To make the situation simple, a draft format of Power of Attorney is enclosed herewith, which may be used as reference.

Since the new system will come into force from 1.1.2003, it would be preferable to submit the registration applications latest by 31.3.2002 and import applications latest by 30.9.2002. However, based on your request, this office has no objection for three months extension period for submission of registration application i.e. latest by 30.06.2002. It is requested that your members may be informed accordingly.

Yours faithfully,

(ASHWINI KUMAR)

Drugs Controller General (India)

No. 18-8/2000-DC

Directorate General of Health Ser vices

Nirman Bhawan, New Delhi

Dated the 1st April 2002

To

All the State Drugs Controllers

Zonal Officers & Port Officers of CDSCO

Sub: - Import and registration vide GSR No. 604 (E) dated 24.8.2001.

Sir,

Please refer to the above subject notification, which shall have come into force from 1.1.2003. A short questionnaire on import and registration has been prepared by this office to clarify various points in the notification, which is being enclosed herewith. The same may please be brought to the notice of the applicants requiring clarification in the matter.

Yours faithfully,

(ASHWINI KUMAR)

Drugs Controller General (India)

QUESTIONAIRE ON IMPORT AND REGISTRATION UNDER GSR 604(E)DT. 24-8-2001

(1) What are the issues involved in GSR 604 (E) dated. 24-8-2001?

Registration of the premises of a foreign manufacturing unit and his manufactured drug for import into India under the Drugs and Cosmetics Rules.

Import of drugs by the domestic importer into India under the Drugs and Cosmetics Rules.

(2) What are the drugs to be allowed for Import Registration?

All the approved biological and non-biological drugs, including bulk drugs, finished formulations, vaccines, certain special products and medical devices.

(3) Who are eligible applicants for the Registration of foreign manufacturing unit and his manufactured drugs.

Application for a Registration Certificate shall be made in Form 40 by a foreign manufacturer by his office in India with a wholesale licence, or by his authorised agent in India either having a manufacturing licence or a whole sale licence.

(4) What will be the documents to accompany a Registration Application?

Bank Challans showing the submission of requisite fees, power of attorney to the Indian counterpart and information in Schedule D-I and D-II.

(5) What will be format of Power of Attorney by a foreign manufacturer to his authorised Agent?

Power of Attorney to accompany an application for issue of Registration Certificate for import of drugs into India, under the Drugs and Cosmetic Rules, 1945.

Whereas, M/s
(Name)___________________________________________ of (full address with telephone, fax and e-mail address ______________________________________________ ______________________, hereinafter to be known as Authorised Agent of us intends to apply for a Registration Certificate under the Drugs and Cosmetics Rules, 1945, for the import, use and marketing into India, of the drugs manufactured by us, we, M/s (name)____________________________________________of (full address with telephone, fax and e-mail address of Registered Office/Global Head Office) hereinafter to be known as the Manufacturer, having factory premises at (full address with telephone, fax, and e-mail address of the manufacturing unit) ______________________________and at (full address, with telephone, fax and e-mail address of manufacturing site functioning conjointly as a single manufacturing unit) _____________________________________, hereby delegate Power of Attorney that for the duration of the said Registration period:-

(1). the said applicant shall be our Authorised Agent for the Registration Certificate of drugs imported into India, under rule 27-A of the Drugs and Cosmetics Rules;

(2). We shall comply with all the conditions imposed on the Registration Certificate, read with rules 74 and 78 of the Drugs and Cosmetics rules, 1945.

(3). We declare that we are carrying on the manufacture of the drugs mentioned in this Schedule, at the premises specified above, and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of functions between the factories:

(4). We shall comply with the provisions of Part IX of the Drugs and Cosmetics Rules, 1945:

(5). Every drug manufactured by us for import under the Registration Certificate into India shall be as regard strength, quality and purity conforms with the provisions of Chapter III of Drugs and Cosmetics Act, 1940 and Part IV of the Drugs and Cosmetics Rules, 1945, and their amendments from time to time:

(6). We shall from time to time report for any change of manufacturing process, or in packaging, or in labeling, or in testing, or in documentation of any of the drugs, pertaining to the Registration Certificate, to be granted to us. Where any change in respect of any of the drugs under the Registration Certificate has taken place, in respect of any of the above matters, we shall inform the same to the licensing authority, in writing within 30 days from the date of such changes. In such cases, where there will be any major change/modification in manufacturing or in processing or in testing, or in documentation, as the case may be, at the discretion of the licensing authority, we shall obtain necessary approval within 30 days by submitting a separate application, alongwith the registration fee as specified in clause (ii) of sub rule (3) of rule 24-A.

(7). We shall from time to time report for any administrative action taken due to adverse reaction, viz. market withdrawal regulatory restriction, or cancellation of authorisation and/or â€œ not of standard quality reportâ€ of any drug pertaining to the Registration Certificate declared by any Regulatory Authority of any country where the drug is marketed/sold or distributed. The despatch and marketing of the drug in such cases, shall be stopped immediately and the licensing authority shall be informed immediately. Further action in respect of stop marketing of drug shall be taken as per the directions of the licensing authority. In such cases, action equivalent to that taken with reference to the concerned drug(s) in the country of origin or in the country of marketing will be followed in India also, in consultation with the licensing authority. The licensing authority may direct any further modification to this course of action, including the withdrawal of the drug from Indian market within 48 hours time period.

(8). We shall comply with such further requirements, if any, as may be specified, by the Government of India, under the Act and the rules, made thereunder.

(9). We shall allow the licensing authority and/or any person authorised by him in that behalf to enter and inspect the manufacturing premises and to examine the process/procedure and documents in respect of any drug manufactured by us for which the application for Registration Certificate has been made:

(10). We shall allow the licensing authority or any person authorised by him in that behalf to take samples of the drugs concerned for test, analysis or examination, if considered necessary by the licensing authority.

NAME (S) OF THE DRUG(S)

Signature on behalf of Registered Office/Global Head OfficeManufacturing Unit of the manufacturer, with name, designation, date and place.

Signature on behalf of Manufacturing site, functioning conjointly as a single manufacturing unit with name, designation, date and place.

EXECUTED BY THE AUTHORITY MENTIONED UNDER RULE 24-A(2).

Authenticated by the Indian Embassy of the said Country.

Signature on behalf of Authorised Agent in India with name, designation, date and place. (at the back side of the document)

(6). What will be the Registration Fees for a foreign manufacturing premises and each drug.

1500 US$ for the manufacturing premises and 1000 US$ for each drug to be registered.

(7). How the Registration Fees in USD will be deposited into Bank of Baroda, K.G.Marg, New Delhi?

Bank drafts in dollar amounts on any foreign bank in New Delhi obtained from the foreign manufacturer is to be deposited alongwith the triplicate copies of TR Form No.6 at Bank of Baroda. Bank receipt ( Pay in Slip) is to be retained. After 2-3 days, as the amount will be received, the Bank will supply a Original Receipt in Form No. TR-6 which is to be submitted along with the Registration Application.

(8). Is there any provision to pay the fees through Electronic mode of transfer.

Swift mode of transfer is under process.

(9). Is there any provision to deposit Registration Fees to the Banks in other cities in India.

Provision is being made to deposit the fees in specific branches of Bank of Baroda at Mumbai, Chennai and Kolkata.

(10). Can equivalent amount of Indian currenty be deposited as Registration fees?

Not at present.

(11). How the fees for registration of bulk drugs and formulations will be calculated?

Each bulk drug in its base form or salt form or Ester form will be taken as one drug. Each formulation in its specific dosage form will be a single drug irrespective of its strength.

(12). Whether the authorised agent will be responsible for the business activity in India?

Yes Sir.

(13). What will be status of the documents in Schedule D-I and D-II mentioned â€œnotarisedâ€.

Proposal will be made for â€œduly authenticated, preferably notarizedâ€.

(14). What shall be the information furnished in Plant Master File (PMF).

Plant Master File (PMF) shall include the following minimal information in chronological order:-

(a) A guide map of the complete plant. passenger,

(b) Area flow chart of the manufacturing and quality control departments of the plant along with the related departments responsible for the manufacturing activities.

(d) A copy of the Approval/Registration Certificate issued by the Ministry of Health/National Regulatory Authority of the foreign country concerned in respect of the said plant.

(e) A brief summary on the activities of the plant since started, including its research activity, original research products, names of bulk drugs and formulations manufactured for sale, Organogram of the qualified personnel for manufacturing and Quality Control with academic and experience background, Global Sale activities etc.

(f) 15) What shall be information furnished in Drug Master File (DMF). DMF of a Bulk Drug shall include following minimal information chronologically:-

(g) Description in short; brief production process with a flow chart of chemical reactions involved in the manufacturing process; details of the input raw materials with their specifications and sources; equipment details with validation and recorded performance, batch determination, storage criteria of the bulk drug with safety handling if any; details of the stability data both accelerated and real time.

(h) Method of analysis with detailed protocols followed and reference standards used; source and maintenance of reference standards; Limits of impurities as well as related substances and their testing details; lists of equipmentâ€™s for testing with their validation and calibration criteria, batch test reports with batch release certificates; batch release certificate from National control authority wherever applicable.

DMF of a finished formulation shall include following minimal information chronologically:-

(a) Description in short; brief production process; flow chart and summary protocol of the manufacturing process; list of equipmentâ€™s involved; active and inactive raw materials with their sources & specifications; quality control and storage; container preperation, in process control data recording systems with processes like filtration, sterilization, filling, lyophillisation etc; storage criteria in respect of area, temperature, humidity and biosafety control; maintenance and monitoring of control of reference samples and recording systems followed.

(b) Method of analysis with detailed protocols followed and reference standards used; source and maintenance of reference standards; lists of equipmentâ€™s for testing with their validation and calibration criteria; batch test reports and batch release certificates; batch release certificate from National control authority wherever applicable.

(c) Stability data on active substances and finished formulations both accelerated and real time; PMS data available for last 5 years.

(d) Self inspection system.

(16). What shall be quantity of Samples to be submitted in respect of a Bulk drug as well as formulations.

The sample quantity will be as per case to case basis.

(17). What should be the manner of labelling of the drugs?

The labels shall be country specific as per the Drugs & Cosmetics Rules, 1945.

(18) What information to be given for Pharmacological and toxicological aspects of the drug.

An executive summary is to be given mentioning the specific and general pharmacological actions of the drug. Information on toxicity studies, viz, reproductive toxicity, local toxicity and carcinogenic activity should be briefly mentioned.

(19) What information to be given in respect of clinical documentation.

Nothing specific is to be mentioned. A copy of New Drug permission under Rule 122-A is to be enclosed.

(20) What information is to be given in case of a special products.

A product dossier is to be enclosed for information.

(21) What are the specific issues involved for the domestic importers in the present Notification?

(a) Fees for Test Licence of a single drug has been increased from Rs.15 to Rs.100 and an additional fee of Rs.50/- for each additional drug.

(b) Government Hospital and Autonomous Medical Institution can import new drugs for their own patients in small quantities with a fee of Rs.100 for single drug and a fee of Rs.50/- for each additional drug.

(c) Fees for import licence in Form 10 and 10-A has been increased from Rs.50 to Rs.1,000/- for a single drug and Rs.100 for each additional drug.

(d) Now onward Form 9 certificate may be issued by the Indian Agent of the foreign manufacturer for Form 10 licence.

(e) Domestic importers will require no other formalities except to produce Form-9 certificate, copy of the Registration Certificate of the manufacturer to obtain Form 10 or 10-A licence.

Sir,

The GSR 604 (E) dated 24.8.2001 published by the Ministry of Health & Family Welfare has made a provision in the Drugs & Cosmetics Rules that the applicants for registration certificates for import of drugs into India shall submit prescribed fees for registration in US$ only, under the Head of Account â€œ0210- Medical and Public Health 04- Public Health, 104 Fees and Finesâ€ and obtain receipts in this regard. As the Bank of Baroda, K.G. Marg, New Delhi are the designated focal point bank for the Ministry of Health, they have been requested to take necessary steps to initiate the above method of transactions with their bank and intimate to this Ministry. The Bank of Baroda, K.G, Marg, New Delhi has intimated to this Ministry that they are in position to accept Registration Fee in US $ through following mode of transactions: -

(1) Registration Fees in US$ through Demand Draft/ Bank draft on any foreign bank in New Delhi/ Mumbai may be deposited to Bank of Baroda, K.G. Marg, New Delhi along with the triplicate copies of TR Form 6. The draft should be payable to Pay and Account Officer (PAO), DGHS, Nirman Bhawan, New Delhi, under the Head of Account â€œ0210- Medical and Public Health 04- Public Health, 104 Fees and Finesâ€. The bank will provide a receipt, which may be submitted with the Registration Application.

(2) For Swift Mode of Transactions, the Bank has advised to remit the Registration Fees with the following note;

The information may please be circulated widely to all the Trade Associations, Importers, Manufacturers and Traders to simplify the payment of registration fees for submitting the registration applications for import of drugs.

Yours faithfully,

(ASHWINI KUMAR)

Drugs Controller General (India)

Copy for information and necessary action to:

This is with reference to Bank of Baroda letters nos. CURZON/GB dated 25/09/01 and BR/CURZON/NHFW dated 23/05/02 on the above subject. It may also be noted that many applicants desire to submit registration fees at the following branches of Bank of Baroda in Mumbai, Chennai and Kolkata:

Sir,

Further, based on the request from different Pharma Industry Associations and various importers, certain proposals have been considered by the Ministry of Health for administrative clarifications and for amendments in the rules by notification in the Official Gazette. It has been decided that:

1. Fees related to the registration formalities may be deposited in US$ or equivalent amount of Indian Currency,

2. Registration Certificate shall not be required to be accompanied with the application for an import licence under the Rules for the import of in-vitro diagnostic kits and reagents, except for the diagnostics notified from time to time under Section 3 (b) (iv),

3. Schedule D (I) & D (II) may be signed by the Authorized Agent, also,

4. The number of drugs, which may be registered in one Registration Certificate, may be more than three.

This is for your information and necessary action.

Yours faithfully,

(ASHWINI KUMAR)

Drugs Controller General (India)

MOST URGENTSPEED POST

No. 6-2/2002-DC

Directorate General of Health Ser vices

(Drugs Control Section)

Nirman Bhawan, New Delhi

Dated 30th September 2002

To

All Importers of drugs and Pharmaceutical Associations

Subject: - Registration of Foreign Manufacturers for their manufacturing sites and drugs to be imported into India under the Drugs & Cosmetics Rules (GSR No. 604 (E) dated 24/08/2001).

Sir,

Your attention is drawn to the above subject matter. During examination of the registration documents submitted by the applicants, it is seen that many of the foreign manufacturers without their office in India with wholesale licences under the rules, have directly submitted their applications for registration of drugs, not appointing Authorized Agent with Power of Attorney. This is contrary to Rule 24-A of the Drugs & Cosmetics Rules, which prescribes, â€œForm and Manner of application for Registration Certificateâ€. Fees paid by the applicants are not supported by receipts issued by Bank of Baroda, K.G. Marg, New Delhi in TR6 form, which is one of the official document. This creates unnecessary delay in the issue of Registration Certificates.

You are requested to take immediate steps, so that applications for Registration Certificate are submitted only by Indian counterparts (either the foreign manufactures with his own office in India having wholesale licences in Form 20B & 21B, or his Authorized Agent in India having wholesale licences in Form 20B & 21B). Copies of wholesale licences are to be submitted as part of the documents. A copy of Rule 24 â€“ A is enclosed for reference in the matter.

A foreign manufacturer already applied for Registration Certificate, who does not have any Indian Counterpart is to be advised for the appointment of a suitable Authorized Agent with requisite Power of Attorney immediately under intimation to this Directorate.

Yours faithfully,

(ASHWINI KUMAR)

Drugs Controller General (India)

Copy to:

All Port and Zonal Officers of CDSCO.

Copy forwarded for information and necessary action to: -

1. The President, All India Manufacturesâ€™ Organizations,

Jeevan Sahakar, Sir Pherozshah Mehta Road, Mumbai-400001.

2. The President, Association of the Indian Pharmaceuticals Manufacturers,

24-A. Form and manner of application for Registration Certificate.-

(1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid whole sale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules and shall be accompanied by the fee specified in sub-rule (3) and the information and undertakings specified in Schedules D-1 and D-II duly signed by on behalf of the manufacturer.

(2) The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate.

(3) (i) A fee of one thousand and five hundred US dollars shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India.

(ii) A fee of one thousand US dollars shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug:

Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee to accompany shall be one thousand US dollars for each drug.

(4) The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account â€œ0210-Medical and Public Health, 04-Public Health, 104- Fees and Finesâ€.

(5) Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account â€œ0210-Medical and Public Health, 04-Public Health, 104-Fees and Finesâ€, and the original receipt of the said transfer shall be treated as an equivalent to the bank challan subject to the approval by the Bank of Baroda that they have received the payment.

(6) The applicant shall be liable for the payment of a fee of five thousand US dollars for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under rule 22:

(7) A fee of three hundred US dollars shall be paid for a duplicate copy

of the Registration Certificate, if the original is defaced, damaged or lost.â€

(8) No Registration Certificate shall be required under these rules in respect of an inactive bulk substance to be used for a drug formulation, with or without Pharmacopoeial conformity.â€

2[Part XIII
IMPORT OF COSMETICS

129. Statement to accompany imported cosmetics :- All consignments of cosmetics sought to be imported shall be accompanied by an invoice or statement showing the name and quantities of each article of cosmetic included in the consignment and the name and address of the manufacturer.

130. Documents to be supplied to the Collector of Customs :- Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the rules made thereunder, shall be supplied to the Collector of Customs.

131. Procedure for the import of cosmetics :- (1) If the officer appointed at the post of entry by the Central Government has reason to believe that any cosmetic contravenes any of the provisions of the Act or the rules made thereunder he may take sample of the cosmetic from the consignment for inspection. If on examination of the sample defects are noticed the officer shall advice the Commissioner of Customs for further action to be taken.

____________________

2. Added by Not. No. F. 1-36/64-D dt. 17.8.1964.

If suspected contravention of the provisions of the Act or the rules is such as may have to be determined by test, the officer shall send the sample to the laboratory established for the purpose for performing such tests. The consignment of the said cosmetic shall be detained till such time that the test report on such sample is received from the Director of the said laboratory or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Government.

Provided that if the importer gives an undertaking in writing not to dispose of the cosmetic without the consent of the Commissioner of Customs and to return the consignment or such portion thereof as may be required, the Commissioner of Customs shall make over the consignment to the importer.

(2) If the importer who has given an undertaking under the proviso to sub-rule (1) is required by the Collector of Customs to return the consignment or portion thereof, he shall return the consignment or portion thereof within ten days of receipt of the notice.

Further Procedure on receipt of the report of analysis

(3) If the Director of the laboratory established for the purpose by the Central Government or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Government, reports to the Commissioner of Customs or to the officer mentioned in sub-rule (1) above that the sample of any cosmetic in a consignment contravenes the provisions of Chapter III of the Act or the rules made thereunder and that the contravention is such that it cannot be remedied by the importer, the Commissioner of Customs shall communicate the report forthwith to the importer who shall within two months of receiving such a communication either send back all the cosmetic of that description in the consignment to the country in which it was manufactured or to the country from which it was imported or hand it over to the Central Government which shall cause it to be destroyed.

Provided that the importer may within thirty days of receipt of the report make a representation against the report to the Commissioner of Customs who shall forward the representation with a fresh sample of the cosmetic to the Drugs Controller, India, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory shall pass orders thereon which shall be final.

(4) If the Drugs Controller or any other officer empowered by him in this behalf with the approval of Central Government reports to the Commissioner of Customs after inspection of the sample of cosmetic and if necessary, after obtaining a test report thereon that the sample of the said cosmetic contravenes in any respect the provisions of Chapter III of the Act or the rules made thereunder but that the contravention is such that it can be remedied by the importer, the Commissioner of Customs shall communicate the report forthwith to the importer and permit him to import the cosmetic without permission of the officer authorised in this behalf by the Central Government.

132. Exemption of cosmetics :- Cosmetics as may be specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and the rules made thereunder to the extent and subject to the conditions specified in that Schedule.

133. Import through points of entry :- No cosmetic shall be imported into India except through the points of entry specified in Rule 43-A

1[134. Cosmetic to contain Dyes, Colours and Pigments :- No Cosmetic shall contain Dyes, Colours and Pigment other than those specified by the Bureau of Indian Standards (IS: 4707 Part I as amended) and Schedule Q.

The permitted Synthetic Organic Colours and Natural Organic colours used in the Cosmetics shall not contain more thanâ€”

(i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.

(ii) 20 parts per million of Lead calculated as Lead.

(iii) 100 parts per million of Heavy Metals other than Lead calculated as the total of the respective metals.]

136. Import of cosmetics for personal use :- Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditionsâ€”

(i) The cosmetics shall form part of a passengers baggage and shall be the property of, and intended for, the bona fide use of passenger; and

(ii) The cosmetic shall be declared to the Customs authorities if they so direct.